OM t of c.iii - Vision Research Coordinating Center - Washington ...

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2/1/99 Chapter 2 Study Design page 2-1 2.1 CLEK Study Summary Chapter 2 Study Design, Timetable and Rationale Keratoconus is a visually disabling thinning disorder of the central cornea that results in irregular astigmatism, progressive corneal distortion, and corneal scarring (Krachmer et al., 1984). The astigmatism and distortion are usually treated with rigid contact lenses. When severe scarring occurs, or when the visual distortion is beyond optical correction, in 10 to 20% of patients, the cornea is repaired or replaced by surgery (Kennedy et al., 1986). The Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study is a multi-center, observational study designed to describe the course of this chronic ocular disease and to determine the associations among its visual and physiological manifestations. One thousand keratoconus patients are enrolled at 16 Participating Clinics over the course of ten months. Each is examined at baseline and annually for at least three years. Examinations include visual acuity, manifest refraction, patientreported quality of life, keratometry, photodocumentation of the cornea to identify central corneal scarring, and slit lamp biomicroscopy. In rigid contact lens wearers, the fluorescein pattern of the patient’s lenses is documented. The flattest CLEK Study trial lens that demonstrates an apical clearance fluorescein pattern is photodocumented in all patients. The CLEK Study characterizes keratoconus over the course of the disease both by initially enrolling patients at various diseases stages and by following all those patients for three years. The goal is to characterize the disease across its course and to identify risk factors and protective factors that determine the severity and progression of the disease. 2.1.1 CLEK Study Timetable Each Clinic is expected to enroll at least 80 patients in a 10-month period, and patients are followed annually for nine years for a total of eight visits. Participating Clinics are reimbursed by the Study Chairman’s office for each CLEK Study patient visit ($300 for each visit). Patients are reimbursed $20 for each Study Visit. Participating Clinics and their referring doctors continue to administer all routine eye care, contact lens care, and surgical care to CLEK Study patients on their usual fee-for-service basis.
2/1/99 Chapter 2 Study Design page 2-2 2.1.2 CLEK Study Calendar Month Event Who’s Primarily Involved October 1994 to May 1995 Startup, central training meeting Chairman, CLEK Photography Reading Center (CPRC), Coordinating Center , Participating Clinics June 1995 to April 1996 Enrollment Participating Clinics, Coordinating Center October 1995 Enrollment review Data Monitoring and Over Committee June 1996 to June 1997 1-year follow-up Participating Clinics, Coordinating Center June 1997 to June 1998 2-year follow-up Participating Clinics, Coordinating Center June 1998 Interim status or progress Data Monitoring and Over review Committee June 1998 to June 1999 3-year follow-up vs. more enrollment Participating Clinics, Coordinating Center June 1999 to July 2004 4-8 year follow-up Chairman, CLEK Photography Reading Center (CPRC), Coordinating Center, CLEK Topography Reading Center, Participating Clinics July 2004-September 2004 Data analysis, manuscript writing 2.2 Specific Aims Chairman, Coordinating C CPRC, CTRC, Writing Committees 2.2.1 Specific Aim A. General Description of the Course of Keratoconus The Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study will describe the distribution and rate of change in best corrected high and low contrast visual acuity, corneal curvature, the proportion of patients developing incident corneal scarring, and the proportion of patients progressing to surgical intervention. 2.2.2 Specific Aim B. Factors Related to Vision in Keratoconus The CLEK Study will characterize the association between best corrected visual
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